Operationalizing Bispecifics with Other Sites

Operationalizing Bispecifics with Other Sites

Multiple barriers prevent community practices from implementing bispecific antibody therapy, including provider concerns about toxicities, pharmacy REMS requirements, and administrative safety concerns despite recognizing revenue potential. Educational partnerships between academic centers and community practices represent the most effective strategy for expanding access, emphasizing the distinction between acute step-up dosing toxicities and delayed maintenance-phase management.

Referring centers that complete REMS training focus heavily on cytokine release syndrome management, which is exclusively a concern during initial dosing performed at referral centers. Community practices never manage acute CRS, instead handling only the chronic toxicities during maintenance therapy. This fundamental distinction allows academic centers to absorb the high-risk initial dosing while community practices manage the more straightforward maintenance phase.

Significant geographic referral areas (Ohio, Pennsylvania, upstate New York, Indiana) require coordinated approaches to enable local maintenance delivery after centralized step-up dosing. Large referral centers maintain multiple BCMA-directed bispecifics on formulary to accommodate different REMS enrollments at referring centers, preventing patients from being unable to continue therapy locally due to REMS program mismatches. Educational outreach comparing current challenges to early daratumumab implementation, when infusion reaction fears proved excessive after first-dose experience, helps contextualize safety concerns. The goal is widespread capability for maintenance bispecific administration at community sites, with academic centers performing initial high-risk dosing, similar to the successful model established for daratumumab.